SuicideNCT02576834
Suicide Prevention Among Substance Abusing Homeless Youth
A study testing Cognitive Therapy for Suicide Prevention and Services as Usual in people with Suicide, run by Ohio State University at 1 site in United States.
Trial summary
The literature is characterized by a dearth of information on interventions for homeless youth, and no suicide prevention intervention has been tested with these youth. Such focus is critical as suicide is the leading cause of death among homeless youth. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- Cognitive Therapy for Suicide Prevention and Services as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-24
- meet McKinney Vento definition for homelessness.
- Youth reports at least one episode of severe suicide ideation in the past 90 days.
Who cannot join
- Evidence of unremitted psychosis or other condition which would impair youth's ability to understand and participate in the research.
- Youth requires psychiatric hospitalization.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Department of Human Development and Family Science
Columbus, Ohio, 43210
About this study
The literature is characterized by a dearth of information on interventions for homeless youth, and no suicide prevention intervention has been tested with these youth. Such focus is critical as suicide is the leading cause of death among homeless youth. Therefore, this study seeks to address this gap in the research literature with the goal to identify an effective strategy to intervene in suicide ideation in this population.
Read the detailed description
While research on homeless youth is increasing, there is a dearth of information regarding effective interventions for these youth. This is of significant concern because studies indicate that 70-95% report problem alcohol or drug use and 66% to 89% of homeless youth have a mental health disorder. Suicide is the leading cause of death with up to 68% of youth reporting a lifetime suicide attempt. Among those who have attempted, an average of 6.2 attempts is reported. In addition, lifetime suicide ideation rates have ranged from 14% to 66.5%. Some predictors of suicide among homeless youth have been identified. These include substance use, childhood physical and sexual abuse, victimization experiences while living on the streets, and psychological functioning, including depression, hopelessness, distress tolerance, impulse control, social support, and problem solving. This study uses general cognitive theory, complemented with concepts from two suicide specific theoretical models, to guide our intervention and conceptual change model. Consonant with the pilot R34 announcement, this study's goal is to pilot test an intervention that has previously demonstrated feasibility and promise with adolescent suicide attempters and efficacy with a low-income sample of adults, "The Cognitive Therapy Intervention for Suicide Attempters." One-hundred fifty homeless youth with recent severe suicide ideation will be randomly assigned to the experimental cognitive therapy for suicide prevention (CTSP) + services as usual (SAU) (n=75) or to SAU alone (n=75). SAU includes those services normally offered through a local drop-in center. Follow-up assessments will be conducted at 3, 6, and 9-months post-baseline. It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicide ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over time compared to SAU alone. Furthermore, theoretically-derived mediators will be tested to shed light on mechanisms associated with change. The data from this study will be used to determine the initial efficacy of this promising intervention, and determine whether findings warrant a broader scale effectiveness trial. Ultimately, attention towards reducing suicide risk among these youth has the potential to reduce premature mortality, hospitalization and loss of human capital in a very high risk population of youth.
- Conditions
- Suicide
- Being tested
- Cognitive Therapy for Suicide Prevention, Services as Usual
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Therapy for Suicide PreventionBehavioural
Also called CTSP
10 sessions of cognitive therapy for suicide prevention provided, along with optional 9 booster sessions + SAU
Services as UsualOther
Also called SAU
Services as usually provided in the community
| Study group | Role | What they receive |
|---|---|---|
| CTSP + SAU | Experimental | 10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with optional 9 booster sessions + SAU Receives: Behavioral: Cognitive Therapy for Suicide Prevention; Other: Services as Usual |
| Services as Usual (SAU) | Other | client receives services they would normally receive within the community Receives: Other: Services as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in suicide ideation
suicide ideation assessed at baseline, 3, 6 and 9 months post-baseline using self-report measures
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Natasha Slesnick, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576834
- Sponsor's protocol ID
- 2014B0532
- Other IDs
- R34DA037845
- Status last verified
- Aug 2019
- First submitted
- 10 Oct 2015
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suicide Prevention Among Substance Abusing Homeless Youth
- ClinicalTrials.gov ID
- NCT02576834
- Acronym / sponsor ID
- 2014B0532
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The literature is characterized by a dearth of information on interventions for homeless youth, and no suicide prevention intervention has been tested with these youth. Such focus is critical as suicide is the leading cause of death among homeless youth. Therefore, this study seeks to address this gap in the research literature with the goal to identify an effective strategy to intervene in suicide ideation in this population.
Detailed description
While research on homeless youth is increasing, there is a dearth of information regarding effective interventions for these youth. This is of significant concern because studies indicate that 70-95% report problem alcohol or drug use and 66% to 89% of homeless youth have a mental health disorder. Suicide is the leading cause of death with up to 68% of youth reporting a lifetime suicide attempt. Among those who have attempted, an average of 6.2 attempts is reported. In addition, lifetime suicide ideation rates have ranged from 14% to 66.5%. Some predictors of suicide among homeless youth have been identified. These include substance use, childhood physical and sexual abuse, victimization experiences while living on the streets, and psychological functioning, including depression, hopelessness, distress tolerance, impulse control, social support, and problem solving. This study uses general cognitive theory, complemented with concepts from two suicide specific theoretical models, to guide our intervention and conceptual change model. Consonant with the pilot R34 announcement, this study's goal is to pilot test an intervention that has previously demonstrated feasibility and promise with adolescent suicide attempters and efficacy with a low-income sample of adults, "The Cognitive Therapy Intervention for Suicide Attempters." One-hundred fifty homeless youth with recent severe suicide ideation will be randomly assigned to the experimental cognitive therapy for suicide prevention (CTSP) + services as usual (SAU) (n=75) or to SAU alone (n=75). SAU includes those services normally offered through a local drop-in center. Follow-up assessments will be conducted at 3, 6, and 9-months post-baseline. It is hypothesized that youth receiving CTSP+SAU will show greater reductions in suicide ideation (primary outcome), substance use and depressive symptoms (secondary outcomes) over time compared to SAU alone. Furthermore, theoretically-derived mediators will be tested to shed light on mechanisms associated with change. The data from this study will be used to determine the initial efficacy of this promising intervention, and determine whether findings warrant a broader scale effectiveness trial. Ultimately, attention towards reducing suicide risk among these youth has the potential to reduce premature mortality, hospitalization and loss of human capital in a very high risk population of youth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTSP + SAU | Experimental | Behavioral: Cognitive Therapy for Suicide Prevention, Other: Services as Usual10 sessions of Cognitive Therapy for Suicide Prevention (CTSP) provided over 6 months, with optional 9 booster sessions + SAU |
| Services as Usual (SAU) | Other | Other: Services as Usualclient receives services they would normally receive within the community |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-24
- meet McKinney Vento definition for homelessness.
- Youth reports at least one episode of severe suicide ideation in the past 90 days.
Key exclusion criteria (2 listed)
- Evidence of unremitted psychosis or other condition which would impair youth's ability to understand and participate in the research.
- Youth requires psychiatric hospitalization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Therapy for Suicide PreventionAlso: CTSP10 sessions of cognitive therapy for suicide prevention provided, along with optional 9 booster sessions + SAU | Behavioural | CTSP + SAU |
| Services as UsualAlso: SAUServices as usually provided in the community | Other | CTSP + SAU, Services as Usual (SAU) |
Primary outcome
change in suicide ideation
Time frame: 9 months
suicide ideation assessed at baseline, 3, 6 and 9 months post-baseline using self-report measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy for Suicide Prevention and Services as Usual in people with Suicide, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in suicide ideation (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2019.